NDC 0615-8031

Spironolactone

Spironolactone

Spironolactone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Spironolactone.

Product ID0615-8031_a15f61fe-129d-49ef-a8bc-ca570308ff2d
NDC0615-8031
Product TypeHuman Prescription Drug
Proprietary NameSpironolactone
Generic NameSpironolactone
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-08-29
Marketing CategoryANDA / ANDA
Application NumberANDA040750
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameSPIRONOLACTONE
Active Ingredient Strength25 mg/1
Pharm ClassesAldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0615-8031-30

6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-8031-30) > 5 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2006-08-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8031-39 [00615803139]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-08-29
Inactivation Date2020-01-31

NDC 0615-8031-05 [00615803105]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-08-29
Inactivation Date2020-01-31

NDC 0615-8031-30 [00615803130]

Spironolactone TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA040750
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-08-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SPIRONOLACTONE25 mg/1

OpenFDA Data

SPL SET ID:8c196be9-88f2-423f-b8e6-c9ffd0e025ff
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313096

    • Pharmacological Class

    • Aldosterone Antagonist [EPC]
    • Aldosterone Antagonists [MoA]

    NDC Crossover Matching brand name "Spironolactone" or generic name "Spironolactone"

    NDCBrand NameGeneric Name
    0228-2672SpironolactoneSpironolactone
    0228-2673SpironolactoneSpironolactone
    0228-2803SpironolactoneSpironolactone
    0378-0243Spironolactonespironolactone
    0378-0437Spironolactonespironolactone
    0378-2146Spironolactonespironolactone
    0603-5763Spironolactonespironolactone
    0603-5764Spironolactonespironolactone
    0603-5765Spironolactonespironolactone
    0615-1535Spironolactonespironolactone
    0615-5592Spironolactonespironolactone
    0615-6591Spironolactonespironolactone
    0615-8031Spironolactonespironolactone
    0615-8178Spironolactonespironolactone
    0615-8221Spironolactonespironolactone
    0781-1599SpironolactoneSpironolactone
    68071-1992SpironolactoneSpironolactone
    68071-3112SpironolactoneSpironolactone
    68071-3375SpironolactoneSpironolactone
    68071-4073SpironolactoneSpironolactone
    68071-4374SpironolactoneSpironolactone
    68084-207SpironolactoneSpironolactone
    68084-208SpironolactoneSpironolactone
    68084-206SpironolactoneSpironolactone
    68151-2776SpironolactoneSpironolactone
    68382-661spironolactonespironolactone
    68382-662spironolactonespironolactone
    68382-660spironolactonespironolactone
    68788-7051SpironolactoneSpironolactone
    68788-6332SpironolactoneSpironolactone
    68788-6895SpironolactoneSpironolactone
    68788-6900SpironolactoneSpironolactone
    68788-9227SpironolactoneSpironolactone
    68788-7019SpironolactoneSpironolactone
    68788-7258SpironolactoneSpironolactone
    68788-7297SpironolactoneSpironolactone
    68788-9124SpironolactoneSpironolactone
    68788-9729SpironolactoneSpironolactone
    70518-0455SpironolactoneSpironolactone
    70518-0563SpironolactoneSpironolactone
    70518-0603SpironolactoneSpironolactone
    70518-0630SpironolactoneSpironolactone
    70518-1334SpironolactoneSpironolactone
    70518-0665SpironolactoneSpironolactone
    70518-1314SpironolactoneSpironolactone
    70518-1746SpironolactoneSpironolactone
    70518-1742SpironolactoneSpironolactone
    70771-1029spironolactonespironolactone
    70771-1028spironolactonespironolactone
    70771-1027spironolactonespironolactone
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